Medical Device Registration and Approval in Indonesia
General country-specific regulatory information is provided on this page for medical device registration and approval in Indonesia. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Indonesia, free of charge, to expedite the preparation of your medical device or IVD registration application.
Medical Device Regulations and Classification in Indonesia
REGULATORY AUTHORITY: Medical devices are regulated by the Indonesian National Agency of Drug and Food Control (NA-DFC).
CLASSIFICATION SYSTEM: Risk Based Classification: Classes I, IIa, IIb and III.
TIMEFRAME: The registration process takes 45 working days for Class I devices, 90 working days for Class IIa and IIb devices, and 120 working days for Class III devices.
LICENSE VALIDITY: Licenses issued in Indonesia expire after 5 years.
AUTHORIZED REPRESENTATIVE: An authorized representative is required.
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